European medicine supply: Access in the spotlight
The European Medicine Agency (EMA) defined a medicine shortage as a “shortage of a medicinal product for human or veterinary use…when supply does not meet demand at a national level.”
The agency clarified the term when it produced two guidance documents for the industry to help address problems in the supply chain.
Late last week, the European Federation for Pharmaceutical Industries and Associations (EFPIA) released a public statement on the side of the industry as to how to counteract shortages.
Its suggestion centered on using the interoperable network of national repositories, set up as part of the Falsified Medicines Directive (FMD), to monitor the supply chain for potential shortages.
The statement explained the EFPIA’s position: “The data stored in the National Medicines Verification Systems could provide useful intelligence regarding the number of packs being supplied by manufacturers on the various European Union (EU) markets as well as on the level of stocks present in the supply chain at country level, and therefore facilitate shortages detection and mitigation.”
In order to implement the idea, the organization stated that input would be needed from national competent authorities and supply chain stakeholders.
The causes of shortages
The root cause of shortages is varied, according to the EFPIA, and includes problems in production and manufacturing consolidation.
One issue in production that has been significant problem for both the EMA and the US Food and Drug Administration (FDA) has been the ongoing contamination of sartan-based and, now, ranitidine medicine.
Due to the widespread recalls of sartan medication, there have been reports that supplies of valsartan are running low, leading to the FDA expediting review of generic applications. The latter medicine is now at the early stages of recalls but, as a commonly prescribed antacid, this could pose a problem if recalls continue.
Pricing policies
An additional factor, referenced by the EFPIA, was the “unintended impacts of pricing and tendering policies.”
The UK is facing such a problem with Vertex’s Orkambi (lumacaftor/ivacaftor), after negotiations over pricing between the UK’s cost-effectiveness regulator, the National Institute for Health and Care Excellence (NICE), and the company have become deadlocked.
As a result, the Labour Party, the opposition political party in the UK, has put forward proposals to use compulsory licensing to make available generic versions of patented products.
In response, the Association for British Pharmaceutical Industries (ABPI)’s Richard Torbett, executive director of commercial policy, said: "The situation on Orkambi is rare, but it is clearly unacceptable, and a solution needs to be found for patients and their families.
“However, ‘compulsory licensing’ – the seizure of new research – is not the answer. It would completely undermine the system for developing new medicines. It would send a hugely negative signal to British scientists and would discourage research in a country that wants to be a leader in innovation.”
